NORMACOL

Transcript

®

Normacol
62%w/w Sterculia

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription but you still need to take
NORMACOL carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 4 days.
- If any of the side effects become serious, or you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

If you need the information on this leaflet in an alternative format,
such as large text, or Braille please ring from the UK: 0800 198 5000.
In this leaflet:
1. What NORMACOL is and what it is used for
2. Before you take NORMACOL
3. How to take NORMACOL
4. Possible side effects
5. How to store NORMACOL
6. Further information

1. What NORMACOL is and what it is used for
NORMACOL granules contain 62% w/w sterculia, which is a vegetable gum from
the karaya tree. It is this natural dietary fibre which helps to relieve constipation
and help keep you regular.
It is also used by people:
• with colostomies or ileostomies,
• who need a high fibre diet, for example in diverticular disease of the colon,
• who have had rectal or anal surgery,
• who have swallowed something sharp to reduce the chance of damage to the
intestine (gut).

2. Before you take NORMACOL
Do not take NORMACOL if your doctor has told you that you have:
• A blockage in your intestine (gut).
• Total loss of muscle tone in the colon.
• Faecal impaction.
• Allergy to any of the ingredients.
Talk to your doctor before taking NORMACOL if you have ulcerative colitis
(an inflammatory disease of the bowel which can cause abdominal pain and
bloody diarrhoea). If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Taking NORMACOL with food and drink
NORMACOL should be taken after meals, always drink plenty of water or
soft drinks.
Pregnancy and breast-feeding
NORMACOL can be taken if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
NORMACOL should not affect your ability to drive or use machines.
Important information about some of the ingredients of NORMACOL
This medicine contains 1.25-2.5 mmol sodium per dose. This should be taken into
consideration by patients on a controlled sodium (low salt) diet.

3. How to take NORMACOL
Always take NORMACOL exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
• The usual dose for adults and the elderly is 1 to 2 sachets, or 1 to 2 heaped 5ml
spoonfuls, taken once or twice a day after meals. Do not take NORMACOL if you
are lying down or just before you go to bed.
• The usual dose for children aged 6 to 12 years old is half the adult dose (half to
1 sachet or half to 1 heaped 5ml spoonful).
If NORMACOL does not work after you have taken it for 4 days, do not take
anymore, and see your doctor or pharmacist.
• To take NORMACOL, put the dry granules on your tongue from the sachet,
spoon or your hand, or just take a few at a time if that is easier.
• Alternatively you can sprinkle NORMACOL onto soft food such as yoghurt.
• Swallow the granules with plenty of water or a cool drink, so that the
oesophagus (gullet) does not become blocked. Never chew or crush the
granules.
If you take more NORMACOL than you should and do not have bowel
movements, see your doctor.
If you forget to take NORMACOL, just take the next normal dose at the usual
time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, NORMACOL can cause side effects, although not everybody
gets them:
• Occasionally NORMACOL causes a swollen stomach.
• Some people may suffer from wind.
• The bowel may become blocked.
• The oesophagus (gullet) can become blocked if NORMACOL is not taken
with enough fluid, or too much NORMACOL is taken.
• Some people may have an allergic reaction which may include an itchy skin,
rash or difficulty in breathing.
• It is not unusual for stool to appear paler in colour than normal as a result of
local contact with sterculia. This does not indicate anything untoward.
If any of the side effects become serious, or you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5. How to store NORMACOL
Keep all medicines out of the reach and sight of children.
Store in a dry place below 25°C.
Do not use NORMACOL after the expiry date which is stated on the sachet/carton
as month/year. The expiry date refers to the last day of the month.

6. Further information
What NORMACOL contains
The active substance is sterculia. The granules contain 62% w/w sterculia.
The other ingredients are sodium hydrogen carbonate, sucrose, talc, titanium dioxide,
hard paraffin and vanillin.
What NORMACOL looks like and contents of the pack
Each carton contains 500 grams of white granules, or if it is a sachet pack, 60 sachets
each containing 7 grams of white granules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Norgine Ltd,
Moorhall Road, Harefield, Middlesex, UB9 6NS, UK.
It is made by Norgine Pharma:
29, rue Ethé Virton - 28100 Dreux - France.
UK Marketing Authorisation Number: PL 00322/5010R
The leaflet was last approved in May 2013.
NORMACOL is a registered trademark.

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